Knowledge, Attitude and Practice on the Severity Classification of Adverse Drug Reactions From Reporting to Review: A Multicenter Cross-Sectional Study in China

Background The severity classification of adverse drug reactions (ADR) is vital for effective clinical decision-making and ensuring patient safety. However, in China, the assessment of ADR severity is fraught with subjectivity and inconsistency, leading to variations in judgments across different institutions and personnel. This study aimed to explore the current practices and challenges in ADR severity classification among healthcare professionals and ADR regulatory agency staffs through a knowledge, attitude, and practice (KAP) survey. Methods A questionnaire was designed based on relevant literature and validated for relevance through pre-experiment using the Content Validity Index (CVI). An online survey platform was utilized to distribute the questionnaire to hospitals and ADR regulatory agencies across 15 provinces in China. Descriptive statistical analysis was employed to characterize demographic variables, with categorical data presented through percentages or frequencies. One-way analysis of variance was conducted to examine associations between participants’ characteristics and KAP scores of ADR severity classification. Results A total of 517 valid questionnaires were collected, 86.5% (n = 447) came from medical institutions and13.5% (n = 70) came from ADR regulatory agency. 97.5% (n = 504) of participants demonstrated awareness of general ADR severity classifications (serious and general). Knowledge grades were significantly higher among ADR regulatory agency staffs compared to other groups, with pharmacists outperforming doctors and nurses. 94% (n = 486) of participants universally acknowledged the importance of ADR severity classification and 91.5% (n = 473) of participants acknowledged its impact on clinical decision-making. 16.1% (n = 83) of participants found current severity definitions practical for real-world application. There are 258(49.9%) participants have participated in the review of ADR reports, and 82.6%(n = 213) of them exhibited discrepancies between initial and review outcomes. Conclusion Pharmacists demonstrated better knowledge regarding ADR severity classification. All participants exhibited positive attitudes toward improving ADR severity classification. There is need for targeted educational interventions and capacity-building programs to standardize ADR severity classification.